Clinical trial · Interventional
Hydroxychloroquine and Temsirolimus in Treating Patients With Metastatic Solid Tumors That Have Not Responded to Treatment
A Phase I Trial of Hydroxychloroquine in Combination With Temsirolimus in Patients With Refractory Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine together with temsirolimus may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of hydroxychloroquine when given together with temsirolimus in treating patients with metastatic solid tumors that have not responded to treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autophagy inhibition therapy | Procedure | — | UNRESOLVED |
| electron microscopy | Other | — | UNRESOLVED |
| high performance liquid chromatography | Other | — | UNRESOLVED |
| hydroxychloroquine | Drug | Hydroxychloroquine | ALIAS |
| immunologic technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mass spectrometry | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum tolerated dose of hydroxychloroquine
Secondary outcomes (3)
- measure
- Response rate
- measure
- Toxicity rate as assessed by NCI CTCAE v. 3.0
- measure
- Pharmacokinetic and pharmacodynamic correlative endpoints
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed refractory solid tumor for which no curative standard therapy exists * Metastatic disease * Treated brain metastases that have been stable ≥ 3 months allowed * At least 1 week since prior steroids PATIENT CHARACTERISTICS: * ECOG performance status of 0-1 * ANC ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine ≤ 2 times upper limit of normal (ULN) * ALT and AST ≤ 5 times ULN * Total bilirubin ≤ 1.5 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No serious concurrent infection or medical illness that would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety * No prior or other concurrent malignancy except for curatively treated carcinoma-in-situ at any site or basal cell carcinoma or squamous cell carcinoma of the skin * Patients who have been free of disease (any prior malignancy) for ≥ 5 years are eligible * No porphyria * No psoriasis, except well controlled psoriasis under the care of a specialist * No previously documented macular degeneration or diabetic retinopathy * No HIV positivity PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Any number and type of prior anticancer therapies allowed * No prior mTOR inhibitors * At least 4 weeks since prior immunotherapy (i.e., aldesleukin, interferon, CTLA-4) or chemotherapy and recovered * At least 2 weeks since prior oral targeted therapy and recovered * At least 4 weeks since prior and no other concurrent investigational anticancer therapy (except for vaccines) * No other concurrent therapy * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent cytochrome P450 enzyme-inducing anticonvulsant drugs (i.e., phenytoin, carbamazepine, phenobarbital, primidone, or oxcarbazepine) * Concurrent non-enzyme inducing anticonvulsants, including felbamate, valproic acid, gabapentin, lamotrigine, tiagabine, topiramate, zonisamide, or levetiracetam allowed * Concurrent hematologic growth factors (filgrastim \[G-CSF\], pegfilgrastim, epoetin alfa) allowed in patients with severe myelosuppression
References
Publications (0)
Data not yet available